Recall Z-0936-2026— Fresenius Medical Care Holdings, Inc.

Name: FDA recall Z-0936-2026
Creator: U.S. Food and Drug Administration
Published: 2025-10-25

Class II · Ongoing

Class II FDA medical device recall by Fresenius Medical Care Holdings, Inc., initiated 2025-10-25. It names one FDA 510(k) clearance: K243505. Product: 5008X CAREsystem +CLiC +CDX;. Reason: Several software anomalies with the potential to impact patient treatment, of which one includes the possibility to result in treatment stop if certain conditions are fulfilled..

Recalling firm: Fresenius Medical Care Holdings, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-10-25
Firm location: Waltham, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K243505 — 5008X Hemodialysis SystemFresenius Medical Care Renal Therapies Group, LLC·cleared 2025-05-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

5008X CAREsystem +CLiC +CDX;

Reason for recall

Several software anomalies with the potential to impact patient treatment, of which one includes the possibility to result in treatment stop if certain conditions are fulfilled.

Data sourced from openFDA. This site is unofficial and independent of the FDA.